ID

23239

Description

Duloxetine for Perimenopausal Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00517985

Link

https://clinicaltrials.gov/show/NCT00517985

Keywords

  1. 6/30/17 6/30/17 -
Uploaded on

June 30, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Major Depressive Disorder NCT00517985

Eligibility Major Depressive Disorder NCT00517985

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women age 40 years old or older.
Description

ID.1

Data type

boolean

Alias
UMLS CUI [1]
C0001779
perimenopausal symptoms of at least 3 months duration, including irregular periods and/or hot flashes.
Description

ID.2

Data type

boolean

Alias
UMLS CUI [1]
C3839366
minimum score of 15 on the hamilton rating scale for depression (17-item).
Description

ID.3

Data type

boolean

Alias
UMLS CUI [1]
C0451203
subjects must be able to be treated on an outpatient basis.
Description

ID.4

Data type

boolean

Alias
UMLS CUI [1]
C0199298
subjects must be able to provide written informed consent.
Description

ID.5

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects presently taking antidepressant medication.
Description

ID.6

Data type

boolean

Alias
UMLS CUI [1]
C0003289
subjects currently using hormone replacement therapy.
Description

ID.7

Data type

boolean

Alias
UMLS CUI [1]
C0019930
subjects who are pregnant.
Description

ID.8

Data type

boolean

Alias
UMLS CUI [1]
C0032961
subjects who have hepatic disease.
Description

ID.9

Data type

boolean

Alias
UMLS CUI [1]
C0023895
other axis i disorders, except generalized anxiety disorder or panic disorder.
Description

ID.10

Data type

boolean

Alias
UMLS CUI [1]
C0270287
"uncontrolled" narrow angle glaucoma.
Description

ID.11

Data type

boolean

Alias
UMLS CUI [1]
C0017605
known hypersensitivity to duloxetine or any of the inactive ingredients.
Description

ID.12

Data type

boolean

Alias
UMLS CUI [1,1]
C0245561
UMLS CUI [1,2]
C0020517
treatment with a monoamine oxidase inhibitor (maoi) within 14 days of study drug administration or potential need to use an maoi during the study or within 5 days of discontinuation of study drug.
Description

ID.13

Data type

boolean

Alias
UMLS CUI [1]
C0026457
presence of psychotic symptoms.
Description

ID.14

Data type

boolean

Alias
UMLS CUI [1]
C0871189
history of mania or hypomania.
Description

ID.15

Data type

boolean

Alias
UMLS CUI [1,1]
C0024713
UMLS CUI [1,2]
C0241934
hamilton rating scale for depression (ham-d) suicide item score > 2.
Description

ID.16

Data type

boolean

Alias
UMLS CUI [1]
C0451203
end stage renal disease or severe renal impairment.
Description

ID.17

Data type

boolean

Alias
UMLS CUI [1]
C0022658
abnormal uterine bleeding that has not been evaluated by a gynecologist (heavy or prolonged uterine bleeding, menstrual periods occurring more frequently than every 3 weeks, bleeding after sexual intercourse, spotting between periods).
Description

ID.18

Data type

boolean

Alias
UMLS CUI [1]
C3650625

Similar models

Eligibility Major Depressive Disorder NCT00517985

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
women age 40 years old or older.
boolean
C0001779 (UMLS CUI [1])
ID.2
Item
perimenopausal symptoms of at least 3 months duration, including irregular periods and/or hot flashes.
boolean
C3839366 (UMLS CUI [1])
ID.3
Item
minimum score of 15 on the hamilton rating scale for depression (17-item).
boolean
C0451203 (UMLS CUI [1])
ID.4
Item
subjects must be able to be treated on an outpatient basis.
boolean
C0199298 (UMLS CUI [1])
ID.5
Item
subjects must be able to provide written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.6
Item
subjects presently taking antidepressant medication.
boolean
C0003289 (UMLS CUI [1])
ID.7
Item
subjects currently using hormone replacement therapy.
boolean
C0019930 (UMLS CUI [1])
ID.8
Item
subjects who are pregnant.
boolean
C0032961 (UMLS CUI [1])
ID.9
Item
subjects who have hepatic disease.
boolean
C0023895 (UMLS CUI [1])
ID.10
Item
other axis i disorders, except generalized anxiety disorder or panic disorder.
boolean
C0270287 (UMLS CUI [1])
ID.11
Item
"uncontrolled" narrow angle glaucoma.
boolean
C0017605 (UMLS CUI [1])
ID.12
Item
known hypersensitivity to duloxetine or any of the inactive ingredients.
boolean
C0245561 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
ID.13
Item
treatment with a monoamine oxidase inhibitor (maoi) within 14 days of study drug administration or potential need to use an maoi during the study or within 5 days of discontinuation of study drug.
boolean
C0026457 (UMLS CUI [1])
ID.14
Item
presence of psychotic symptoms.
boolean
C0871189 (UMLS CUI [1])
ID.15
Item
history of mania or hypomania.
boolean
C0024713 (UMLS CUI [1,1])
C0241934 (UMLS CUI [1,2])
ID.16
Item
hamilton rating scale for depression (ham-d) suicide item score > 2.
boolean
C0451203 (UMLS CUI [1])
ID.17
Item
end stage renal disease or severe renal impairment.
boolean
C0022658 (UMLS CUI [1])
ID.18
Item
abnormal uterine bleeding that has not been evaluated by a gynecologist (heavy or prolonged uterine bleeding, menstrual periods occurring more frequently than every 3 weeks, bleeding after sexual intercourse, spotting between periods).
boolean
C3650625 (UMLS CUI [1])

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